STOP Heart Disease in Breast Cancer Survivors
|Institution:||Cedars-Sinai Medical Center|
Marc Goodman , Ph.D., M.P.H. -
|Award Cycle:||2015 (Cycle 21)||Grant #: 21OB-0136||Award: $1,122,177|
|Award Type:||Translational Research Award|
|Detection, Prognosis and Treatment>Innovative Treatment Modalities: search for a cure|
Initial Award Abstract (2015)
Breast cancer and heart disease are major health concerns for American women. While aggressive screening and advanced treatment for breast cancer have measurably improved how long women live following diagnosis, the treatments for breast cancer may lead to physical impairment such as pain, fatigue, swelling of the arms reduced range of motion, and loss of sensation. What’s not discussed as commonly among women and their doctors is the injury to the heart that can also result from cancer treatment, especially anthracyclines which is associated with considerable damage to the heart. Some of this heart injury is subtle and does not manifest itself immediately, so it can be disregarded at least initially. However, among breast cancer survivors, heart disease can seriously affect quality of life - often 10 to 20 years after cancer cure. In fact, some women diagnosed with breast cancer today will be more likely to die from heart disease than from their breast cancer. Clearly, the question of treatment-related heart disease and follow-up care among women with breast cancer assumes greater significance now that long-term disease-free survival has been achieved.
The question(s) or central hypotheses of the research: We strongly believe that something needs to be done to reduce the added burden of treatment-related heart disease in women with breast cancer. Statins are widely used drugs that lower cholesterol levels and slow the formation of harmful ‘plaques’ in the arteries which reduce the flow of blood. Reduced blood flow can cause heart attacks, stroke, and other harmful problems. Statins appear to rapidly reduce inflammation that may be harmful to heart tissue. In fact, some studies suggest that statins may decrease the risk of heart disease in breast cancer patients, but this possibility has not been studied systematically in a clinical trial. We hypothesize that statins will reduce or eliminate the harmful effects of anthracycline treatment to the heart tissue of breast cancer patients.
The general methodology: Our primary objective is to compare changes to the heart using non-invasive, state-of-the-art techniques called cardiac magnetic resonance imaging (CMRI) and magnetic resonance spectroscopy (MRS) before and after breast cancer treatment in (a) 45 women prescribed statins, and (b) 45 women given a placebo (control). In this clinical trial, we focus on Her2-negative breast cancer patients receiving anthracyclines and cyclophosphamide followed by taxane (AC-T) therapy. CMRI and MRS can detect nuanced changes in the heart that are predictive of heart failure and are thus excellent tools to detect chemotherapy-induced injury.
Innovative elements of the project: Presently, no physician guidelines exist for post-treatment heart disease monitoring among breast cancer survivors. This lack of guidelines for the cardiovascular care of breast cancer patients is understandable because these women are generally excluded from cardiac clinical trials. Information is needed regarding the benefit of implementing measures early to reduce or prevent heart injury among women with the most aggressive types of breast cancer. Statins are well-accepted and well-tolerated medications with significant heart disease benefit. In spite of the substantial evidence that breast cancer treatment may be bad for the heart with long-term consequences to quality of life, randomized trials of statin use and breast cancer recurrence or survival have not been conducted. The management strategies being tested in the STOP Heart Disease in Breast Cancer Survivors trial are logical and consistent with present clinical care of women at risk for cardiac disease, yet novel for the breast cancer population. This trial will be the first to document the feasibility of recruiting breast cancer patients to statin therapy, will evaluate utility and safety of this novel preventive strategy, and will identify key biologic mechanisms through which breast cancer treatment damages the heart. If successful, this study will provide our group with the necessary data to carry-out a multi-center clinical trial with an objective to decrease the unnecessary morbidity and mortality among women with breast cancer.